Trial Outcomes & Findings for Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer (NCT NCT04094688)
NCT ID: NCT04094688
Last Updated: 2026-03-03
Results Overview
Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. Progression-free survival (PFS) will be compared between treatment arms using the un-stratified log-rank test at one-sided level of 0.05 and the p-value will be used for decision making. The hazard ratio (HR) for PFS will be estimated using a Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced. Brookmeyer-Crowley methodology will be used to construct the 95% CI for the median PFS for each treatment arm. All randomized patients regardless of any treatment received will be included in the analysis. Patients will be assigned to the treatment group they were randomized to regardless of actual treatment received.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
455 participants
Primary outcome timeframe
4 years
Results posted on
2026-03-03
Participant Flow
Participant milestones
| Measure |
Arm I (Bevacizumab, Chemotherapy, High-dose Vitamin D3)
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV on days 1-3 or irinotecan hydrochloride IV on day 1, leucovorin calcium IV over 90 minutes on day 1, and fluorouracil IV on days 1-3. Patients also receive high-dose cholecalciferol PO QD on days 1-14. Cycles repeat every 14 days for 5 years in the absence of disease progression or unacceptable toxicity.
\>
\> Bevacizumab: Given IV
\>
\> Oxaliplatin: Given IV
\>
\> Leucovorin Calcium: Given IV
\>
\> Fluorouracil: Given IV
\>
\> Irinotecan Hydrochloride: Given IV
\>
\> Irinotecan: Given IV
\>
\> Cholecalciferol: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Bevacizumab, Chemotherapy, Standard-dose Vitamin D3)
Patients receive bevacizumab and chemotherapy as in Arm I. Patients also receive standard-dose cholecalciferol PO QD on days 1-14. Cycles repeat every 14 days for 5 years in the absence of disease progression or unacceptable toxicity.
\>
\> Bevacizumab: Given IV
\>
\> Oxaliplatin: Given IV
\>
\> Leucovorin Calcium: Given IV
\>
\> Fluorouracil: Given IV
\>
\> Irinotecan Hydrochloride: Given IV
\>
\> Irinotecan: Given IV
\>
\> Cholecalciferol: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
228
|
227
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
228
|
227
|
Reasons for withdrawal
| Measure |
Arm I (Bevacizumab, Chemotherapy, High-dose Vitamin D3)
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV on days 1-3 or irinotecan hydrochloride IV on day 1, leucovorin calcium IV over 90 minutes on day 1, and fluorouracil IV on days 1-3. Patients also receive high-dose cholecalciferol PO QD on days 1-14. Cycles repeat every 14 days for 5 years in the absence of disease progression or unacceptable toxicity.
\>
\> Bevacizumab: Given IV
\>
\> Oxaliplatin: Given IV
\>
\> Leucovorin Calcium: Given IV
\>
\> Fluorouracil: Given IV
\>
\> Irinotecan Hydrochloride: Given IV
\>
\> Irinotecan: Given IV
\>
\> Cholecalciferol: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Bevacizumab, Chemotherapy, Standard-dose Vitamin D3)
Patients receive bevacizumab and chemotherapy as in Arm I. Patients also receive standard-dose cholecalciferol PO QD on days 1-14. Cycles repeat every 14 days for 5 years in the absence of disease progression or unacceptable toxicity.
\>
\> Bevacizumab: Given IV
\>
\> Oxaliplatin: Given IV
\>
\> Leucovorin Calcium: Given IV
\>
\> Fluorouracil: Given IV
\>
\> Irinotecan Hydrochloride: Given IV
\>
\> Irinotecan: Given IV
\>
\> Cholecalciferol: Given PO
\>
\> Quality-of-Life Assessment: Ancillary studies
\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
Disease progression
|
70
|
80
|
|
Overall Study
Withdrawal by Subject
|
38
|
38
|
|
Overall Study
Alternative therapy
|
2
|
3
|
|
Overall Study
Adverse Event
|
20
|
23
|
|
Overall Study
Patient withdrawal prior to beginning therapy
|
8
|
12
|
|
Overall Study
Death
|
4
|
4
|
|
Overall Study
Complicating disease
|
2
|
1
|
|
Overall Study
Disease progression prior to beginning therapy
|
1
|
0
|
|
Overall Study
Still on treatment
|
3
|
1
|
|
Overall Study
Noncompliance
|
12
|
15
|
|
Overall Study
Ineligible
|
1
|
1
|
|
Overall Study
Death prior to beginning treatment
|
2
|
1
|
|
Overall Study
Physician Decision
|
4
|
4
|
|
Overall Study
Clinical deterioration
|
1
|
0
|
|
Overall Study
Clinical progression
|
12
|
5
|
|
Overall Study
Physician and patient decision
|
1
|
1
|
|
Overall Study
Withdrawal by study chair
|
2
|
0
|
|
Overall Study
Clinical intervention
|
1
|
0
|
|
Overall Study
Change in patient insurance coverage
|
1
|
2
|
|
Overall Study
Symptom decline
|
0
|
1
|
|
Overall Study
Withdrawal by sponsor
|
0
|
2
|
Baseline Characteristics
Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Bevacizumab, Chemotherapy, High-dose Vitamin D3)
n=228 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV on days 1-3 or irinotecan hydrochloride IV on day 1, leucovorin calcium IV over 90 minutes on day 1, and fluorouracil IV on days 1-3. Patients also receive high-dose cholecalciferol PO QD on days 1-14. Cycles repeat every 14 days for 5 years in the absence of disease progression or unacceptable toxicity.\>
\> Bevacizumab: Given IV\>
\> Oxaliplatin: Given IV\>
\> Leucovorin Calcium: Given IV\>
\> Fluorouracil: Given IV\>
\> Irinotecan Hydrochloride: Given IV\>
\> Irinotecan: Given IV\>
\> Cholecalciferol: Given PO\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Bevacizumab, Chemotherapy, Standard-dose Vitamin D3)
n=227 Participants
Patients receive bevacizumab and chemotherapy as in Arm I. Patients also receive standard-dose cholecalciferol PO QD on days 1-14. Cycles repeat every 14 days for 5 years in the absence of disease progression or unacceptable toxicity.\>
\> Bevacizumab: Given IV\>
\> Oxaliplatin: Given IV\>
\> Leucovorin Calcium: Given IV\>
\> Fluorouracil: Given IV\>
\> Irinotecan Hydrochloride: Given IV\>
\> Irinotecan: Given IV\>
\> Cholecalciferol: Given PO\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=41 Participants
|
59 years
n=35 Participants
|
59 years
n=76 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=41 Participants
|
91 Participants
n=35 Participants
|
181 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
138 Participants
n=41 Participants
|
136 Participants
n=35 Participants
|
274 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
25 Participants
n=41 Participants
|
24 Participants
n=35 Participants
|
49 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
193 Participants
n=41 Participants
|
192 Participants
n=35 Participants
|
385 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
21 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
6 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
25 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
79 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
153 Participants
n=41 Participants
|
152 Participants
n=35 Participants
|
305 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
37 Participants
n=76 Participants
|
|
Region of Enrollment
Puerto Rico
|
2 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=76 Participants
|
|
Region of Enrollment
United States
|
226 Participants
n=41 Participants
|
226 Participants
n=35 Participants
|
452 Participants
n=76 Participants
|
|
ECOG Performance Score
0
|
120 Participants
n=41 Participants
|
118 Participants
n=35 Participants
|
238 Participants
n=76 Participants
|
|
ECOG Performance Score
1
|
108 Participants
n=41 Participants
|
109 Participants
n=35 Participants
|
217 Participants
n=76 Participants
|
|
Body-Mass Index
< 25
|
75 Participants
n=41 Participants
|
78 Participants
n=35 Participants
|
153 Participants
n=76 Participants
|
|
Body-Mass Index
25 to 30
|
70 Participants
n=41 Participants
|
62 Participants
n=35 Participants
|
132 Participants
n=76 Participants
|
|
Body-Mass Index
>= 30
|
67 Participants
n=41 Participants
|
69 Participants
n=35 Participants
|
136 Participants
n=76 Participants
|
|
Body-Mass Index
Missing
|
16 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
34 Participants
n=76 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPer Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. Progression-free survival (PFS) will be compared between treatment arms using the un-stratified log-rank test at one-sided level of 0.05 and the p-value will be used for decision making. The hazard ratio (HR) for PFS will be estimated using a Cox proportional hazards model and the 95% confidence interval (CI) for the HR will be provided. Kaplan-Meier methodology will be used to estimate the median PFS for each treatment arm, and Kaplan-Meier curves will be produced. Brookmeyer-Crowley methodology will be used to construct the 95% CI for the median PFS for each treatment arm. All randomized patients regardless of any treatment received will be included in the analysis. Patients will be assigned to the treatment group they were randomized to regardless of actual treatment received.
Outcome measures
| Measure |
Arm I (Bevacizumab, Chemotherapy, High-dose Vitamin D3)
n=228 Participants
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oxaliplatin IV over 2 hours on day 1, leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV on days 1-3 or irinotecan hydrochloride IV on day 1, leucovorin calcium IV over 90 minutes on day 1, and fluorouracil IV on days 1-3. Patients also receive high-dose cholecalciferol PO QD on days 1-14. Cycles repeat every 14 days for 5 years in the absence of disease progression or unacceptable toxicity.\>
\> Bevacizumab: Given IV\>
\> Oxaliplatin: Given IV\>
\> Leucovorin Calcium: Given IV\>
\> Fluorouracil: Given IV\>
\> Irinotecan Hydrochloride: Given IV\>
\> Irinotecan: Given IV\>
\> Cholecalciferol: Given PO\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
Arm II (Bevacizumab, Chemotherapy, Standard-dose Vitamin D3)
n=227 Participants
Patients receive bevacizumab and chemotherapy as in Arm I. Patients also receive standard-dose cholecalciferol PO QD on days 1-14. Cycles repeat every 14 days for 5 years in the absence of disease progression or unacceptable toxicity.\>
\> Bevacizumab: Given IV\>
\> Oxaliplatin: Given IV\>
\> Leucovorin Calcium: Given IV\>
\> Fluorouracil: Given IV\>
\> Irinotecan Hydrochloride: Given IV\>
\> Irinotecan: Given IV\>
\> Cholecalciferol: Given PO\>
\> Quality-of-Life Assessment: Ancillary studies\>
\> Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Progression-free Survival (PFS)
|
11.8 months
Interval 10.3 to 13.3
|
10.3 months
Interval 9.4 to 12.2
|
SECONDARY outcome
Timeframe: Up to 5 yearsPer Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Will be estimated using objective response rate (ORR) where ORR is defined as the number of evaluable patients achieving a response (partial response or complete response per RECIST v1.1) during treatment with study therapy divided by the total number of evaluable patients. Rates of response will be compared across arms using a Chi-Square test for proportion. Point estimates will be generated for objective response rates within each arm along with 95% binomial confidence intervals. All randomized patients regardless of any treatment received will be included in the analysis. Patients will be assigned to the treatment group they were randomized to regardless of actual treatment received.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to death due to any cause, assessed up to 5 yearsThe distribution of survival time will be estimated using the method of Kaplan-Meier. Overall survival (OS) will be compared between treatment arms using the log-rank test. OS medians, survival rates at 3 years, and hazard ratio (HR) will be estimated along with 95% confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsAs per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Toxicity is defined as adverse events that are classified as possibly, probably, or definitely related to study treatment. Toxicities will be evaluated via the ordinal CTCAE standard toxicity grading. Overall toxicity incidence as well as toxicity profiles by treatment arm will be explored and summarized. Frequency distributions, graphical techniques, and other descriptive measures will form the basis of the analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsProgression-free survival (PFS) of patients receiving high-dose vitamin D3 versus (vs.) patients receiving standard-dose vitamin D3 will be compared in subgroups of physical activity (PA) levels. The levels will be defined as low PA (\< 9 metabolic-equivalent task \[MET\]-hours/week) vs. high PA (\>= 9 MET-hours/week). The distribution of PFS time will be estimated using the method of Kaplan-Meier within each subgroup and arm combination. PFS will be compared between treatment arms using the non-stratified log-rank test in each subgroup of PA levels. PFS medians, survival rates at 3 years, and hazard ratio (HR) will be estimated along with 95% confidence intervals within each subgroup and arm combination. Interaction between PA subgroups and treatment arms will be tested using likelihood ratio test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baselineThe baseline incidence of vitamin D3 deficiency will be defined as the number of evaluable vitamin D3 deficient patients divided by the total number of evaluable patients. The population of evaluable patients for this analysis will be all patients whose calcifediol (25(OH)D) level was successfully measured at baseline. Vitamin D3 deficiency is defined as 25(OH)D level \< 20 ng/mL. Incidence rates of vitamin D3 deficiency will be compared across arms using a Chi-Square test for proportion. Point estimates will be generated for vitamin D3 deficiency rates within each arm along with 95% confidence intervals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At baselineProgression-free survival (PFS) of patients receiving high-dose vitamin D3 vs. patients receiving standard-dose vitamin D3 will be compared in subgroups of baseline 25(OH)D levels. The levels will be defined as deficient (\< 20 ng/mL) vs. other (\>= 20 ng/mL). The distribution of PFS time will be estimated using the method of Kaplan-Meier within each subgroup and arm combination. PFS will be compared between treatment arms using the non-stratified log-rank test in each subgroup of baseline 25(OH)D levels. PFS medians, survival rates at 3 years, and hazard ratio (HR) will be estimated along with 95% confidence intervals within each subgroup and arm combination. Interaction between baseline 25(OH)D level subgroups and treatment arms will be tested using likelihood ratio test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsProgression-free survival (PFS) of patients will be compared in subgroups of highest achieved 25(OH)D levels. The levels will be defined by quartile of highest-achieved level among patients who have both baseline and at least one on-treatment 25(OH)D sample result. The distribution of PFS time will be estimated using the method of Kaplan-Meier within each subgroup. PFS will be compared across quartiles using the non-stratified log-rank test. PFS medians, survival rates at 3 years, and hazard ratio (HR) will be estimated along with 95% confidence intervals. Baseline 25(OH)D will be entered into the Cox model as a covariate.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Bevacizumab, Chemotherapy, High-dose Vitamin D3)
Serious events: 85 serious events
Other events: 204 other events
Deaths: 120 deaths
Arm II (Bevacizumab, Chemotherapy, Standard-dose Vitamin D3)
Serious events: 89 serious events
Other events: 206 other events
Deaths: 112 deaths
Serious adverse events
| Measure |
Arm I (Bevacizumab, Chemotherapy, High-dose Vitamin D3)
n=228 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm II (Bevacizumab, Chemotherapy, Standard-dose Vitamin D3)
n=227 participants at risk
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Ileal obstruction
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Ileus
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
2.6%
6/228 • Number of events 6 • 4 years
|
5.3%
12/227 • Number of events 13 • 4 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.3%
3/228 • Number of events 4 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Stomach pain
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
6/228 • Number of events 6 • 4 years
|
4.4%
10/227 • Number of events 12 • 4 years
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
General disorders and administration site conditions
Disease progression
|
0.00%
0/228 • 4 years
|
1.3%
3/227 • Number of events 3 • 4 years
|
|
General disorders and administration site conditions
Edema face
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
General disorders and administration site conditions
Edema limbs
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
General disorders and administration site conditions
Fatigue
|
1.3%
3/228 • Number of events 3 • 4 years
|
2.2%
5/227 • Number of events 5 • 4 years
|
|
General disorders and administration site conditions
Fever
|
0.44%
1/228 • Number of events 1 • 4 years
|
2.2%
5/227 • Number of events 6 • 4 years
|
|
General disorders and administration site conditions
Sudden death NOS
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Immune system disorders
Allergic reaction
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Infections and infestations
Biliary tract infection
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Infections and infestations
Bladder infection
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Infections and infestations
Device related infection
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Infections and infestations
Lung infection
|
2.2%
5/228 • Number of events 6 • 4 years
|
1.8%
4/227 • Number of events 4 • 4 years
|
|
Infections and infestations
Peritoneal infection
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Infections and infestations
Sepsis
|
1.8%
4/228 • Number of events 4 • 4 years
|
4.0%
9/227 • Number of events 9 • 4 years
|
|
Infections and infestations
Skin infection
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Infections and infestations
Urinary tract infection
|
0.44%
1/228 • Number of events 1 • 4 years
|
1.3%
3/227 • Number of events 3 • 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Injury, poisoning and procedural complications
Intestinal stoma site bleeding
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Injury, poisoning and procedural complications
Small intestinal anastomotic leak
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Investigations
Blood bilirubin increased
|
1.3%
3/228 • Number of events 3 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Investigations
Cardiac troponin I increased
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Investigations
Creatinine increased
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Investigations
Ejection fraction decreased
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Investigations
Investigations - Other, specify
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Investigations
Lymphocyte count decreased
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Investigations
Neutrophil count decreased
|
7.0%
16/228 • Number of events 18 • 4 years
|
4.0%
9/227 • Number of events 9 • 4 years
|
|
Investigations
Platelet count decreased
|
1.8%
4/228 • Number of events 4 • 4 years
|
1.3%
3/227 • Number of events 4 • 4 years
|
|
Investigations
Weight loss
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Investigations
White blood cell decreased
|
2.6%
6/228 • Number of events 7 • 4 years
|
2.2%
5/227 • Number of events 5 • 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.88%
2/228 • Number of events 2 • 4 years
|
1.3%
3/227 • Number of events 3 • 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.88%
2/228 • Number of events 2 • 4 years
|
1.8%
4/227 • Number of events 4 • 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.88%
2/228 • Number of events 3 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.44%
1/228 • Number of events 1 • 4 years
|
1.8%
4/227 • Number of events 6 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Nervous system disorders
Cognitive disturbance
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Nervous system disorders
Dizziness
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Nervous system disorders
Headache
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
0.44%
1/228 • Number of events 2 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.88%
2/228 • Number of events 3 • 4 years
|
1.3%
3/227 • Number of events 9 • 4 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Nervous system disorders
Stroke
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Pregnancy, puerperium and perinatal conditions
Pregn, puerperium, perntl cond -Oth spec
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.88%
2/228 • Number of events 3 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Renal and urinary disorders
Hematuria
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Renal and urinary disorders
Proteinuria
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.2%
5/228 • Number of events 5 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/228 • 4 years
|
1.8%
4/227 • Number of events 5 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Vascular disorders
Hematoma
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Vascular disorders
Hypertension
|
2.6%
6/228 • Number of events 7 • 4 years
|
2.2%
5/227 • Number of events 11 • 4 years
|
|
Vascular disorders
Hypotension
|
1.3%
3/228 • Number of events 3 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Vascular disorders
Superior vena cava syndrome
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Vascular disorders
Thromboembolic event
|
2.6%
6/228 • Number of events 6 • 4 years
|
3.1%
7/227 • Number of events 7 • 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
2.2%
5/228 • Number of events 6 • 4 years
|
2.2%
5/227 • Number of events 6 • 4 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.44%
1/228 • Number of events 1 • 4 years
|
1.8%
4/227 • Number of events 4 • 4 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/228 • 4 years
|
1.3%
3/227 • Number of events 3 • 4 years
|
|
Cardiac disorders
Chest pain - cardiac
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Cardiac disorders
Heart failure
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Cardiac disorders
Myocardial infarction
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.1%
14/228 • Number of events 14 • 4 years
|
4.8%
11/227 • Number of events 13 • 4 years
|
|
Gastrointestinal disorders
Anal fistula
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Bloating
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Colitis
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.88%
2/227 • Number of events 3 • 4 years
|
|
Gastrointestinal disorders
Colonic fistula
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Colonic obstruction
|
3.5%
8/228 • Number of events 8 • 4 years
|
1.8%
4/227 • Number of events 4 • 4 years
|
|
Gastrointestinal disorders
Colonic perforation
|
1.8%
4/228 • Number of events 4 • 4 years
|
1.8%
4/227 • Number of events 4 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
2.6%
6/228 • Number of events 6 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
6/228 • Number of events 7 • 4 years
|
4.0%
9/227 • Number of events 10 • 4 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
Other adverse events
| Measure |
Arm I (Bevacizumab, Chemotherapy, High-dose Vitamin D3)
n=228 participants at risk
Questionnaire Administration: Ancillary studies
|
Arm II (Bevacizumab, Chemotherapy, Standard-dose Vitamin D3)
n=227 participants at risk
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
General disorders and administration site conditions
Edema face
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
General disorders and administration site conditions
Edema limbs
|
6.6%
15/228 • Number of events 83 • 4 years
|
5.7%
13/227 • Number of events 55 • 4 years
|
|
General disorders and administration site conditions
Facial pain
|
2.2%
5/228 • Number of events 16 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
General disorders and administration site conditions
Fatigue
|
53.5%
122/228 • Number of events 765 • 4 years
|
52.9%
120/227 • Number of events 726 • 4 years
|
|
General disorders and administration site conditions
Fever
|
4.8%
11/228 • Number of events 23 • 4 years
|
6.2%
14/227 • Number of events 18 • 4 years
|
|
General disorders and administration site conditions
Flu like symptoms
|
2.2%
5/228 • Number of events 6 • 4 years
|
1.8%
4/227 • Number of events 10 • 4 years
|
|
General disorders and administration site conditions
Gait disturbance
|
2.6%
6/228 • Number of events 36 • 4 years
|
0.88%
2/227 • Number of events 3 • 4 years
|
|
General disorders and administration site conditions
Gen disord and admin site conds-Oth spec
|
2.6%
6/228 • Number of events 16 • 4 years
|
4.8%
11/227 • Number of events 126 • 4 years
|
|
General disorders and administration site conditions
Generalized edema
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
General disorders and administration site conditions
Localized edema
|
0.44%
1/228 • Number of events 12 • 4 years
|
0.88%
2/227 • Number of events 29 • 4 years
|
|
General disorders and administration site conditions
Malaise
|
2.2%
5/228 • Number of events 7 • 4 years
|
1.8%
4/227 • Number of events 4 • 4 years
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
3.9%
9/228 • Number of events 15 • 4 years
|
4.0%
9/227 • Number of events 13 • 4 years
|
|
General disorders and administration site conditions
Pain
|
10.5%
24/228 • Number of events 80 • 4 years
|
12.8%
29/227 • Number of events 107 • 4 years
|
|
Immune system disorders
Allergic reaction
|
0.88%
2/228 • Number of events 5 • 4 years
|
0.88%
2/227 • Number of events 3 • 4 years
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 7 • 4 years
|
|
Infections and infestations
Bladder infection
|
0.88%
2/228 • Number of events 3 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Infections and infestations
Bronchial infection
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
Infections and infestations
Eye infection
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Infections and infestations
Folliculitis
|
0.44%
1/228 • Number of events 4 • 4 years
|
0.00%
0/227 • 4 years
|
|
Infections and infestations
Herpes simplex reactivation
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 6 • 4 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
3.1%
7/228 • Number of events 8 • 4 years
|
1.8%
4/227 • Number of events 7 • 4 years
|
|
Infections and infestations
Lung infection
|
1.3%
3/228 • Number of events 4 • 4 years
|
0.00%
0/227 • 4 years
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Infections and infestations
Nail infection
|
1.3%
3/228 • Number of events 5 • 4 years
|
0.00%
0/227 • 4 years
|
|
Infections and infestations
Otitis externa
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Infections and infestations
Otitis media
|
0.44%
1/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/228 • 4 years
|
1.3%
3/227 • Number of events 3 • 4 years
|
|
Infections and infestations
Pharyngitis
|
0.88%
2/228 • Number of events 3 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Infections and infestations
Rash pustular
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Infections and infestations
Shingles
|
1.3%
3/228 • Number of events 6 • 4 years
|
1.3%
3/227 • Number of events 5 • 4 years
|
|
Infections and infestations
Sinusitis
|
1.8%
4/228 • Number of events 5 • 4 years
|
0.88%
2/227 • Number of events 3 • 4 years
|
|
Infections and infestations
Skin infection
|
2.2%
5/228 • Number of events 7 • 4 years
|
1.8%
4/227 • Number of events 6 • 4 years
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Infections and infestations
Stoma site infection
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 5 • 4 years
|
|
Infections and infestations
Thrush
|
1.8%
4/228 • Number of events 6 • 4 years
|
1.8%
4/227 • Number of events 5 • 4 years
|
|
Infections and infestations
Tooth infection
|
1.3%
3/228 • Number of events 4 • 4 years
|
1.8%
4/227 • Number of events 5 • 4 years
|
|
Infections and infestations
Upper respiratory infection
|
1.8%
4/228 • Number of events 10 • 4 years
|
2.2%
5/227 • Number of events 9 • 4 years
|
|
Infections and infestations
Urinary tract infection
|
3.1%
7/228 • Number of events 22 • 4 years
|
4.0%
9/227 • Number of events 18 • 4 years
|
|
Infections and infestations
Vaginal infection
|
0.44%
1/228 • Number of events 2 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Infections and infestations
Wound infection
|
0.44%
1/228 • Number of events 3 • 4 years
|
0.00%
0/227 • 4 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.44%
1/228 • Number of events 3 • 4 years
|
0.44%
1/227 • Number of events 16 • 4 years
|
|
Injury, poisoning and procedural complications
Bruising
|
2.6%
6/228 • Number of events 8 • 4 years
|
0.88%
2/227 • Number of events 5 • 4 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.2%
5/228 • Number of events 9 • 4 years
|
2.6%
6/227 • Number of events 8 • 4 years
|
|
Injury, poisoning and procedural complications
Fracture
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.8%
11/228 • Number of events 28 • 4 years
|
4.0%
9/227 • Number of events 13 • 4 years
|
|
Injury, poisoning and procedural complications
Inj, pois and proced complic - Oth spec
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Injury, poisoning and procedural complications
Intestinal stoma site bleeding
|
0.88%
2/228 • Number of events 5 • 4 years
|
0.44%
1/227 • Number of events 5 • 4 years
|
|
Injury, poisoning and procedural complications
Prolapse of intestinal stoma
|
0.44%
1/228 • Number of events 8 • 4 years
|
0.00%
0/227 • 4 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.44%
1/228 • Number of events 1 • 4 years
|
1.3%
3/227 • Number of events 61 • 4 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.44%
1/228 • Number of events 4 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Investigations
Alanine aminotransferase increased
|
11.4%
26/228 • Number of events 111 • 4 years
|
15.4%
35/227 • Number of events 158 • 4 years
|
|
Investigations
Alkaline phosphatase increased
|
19.7%
45/228 • Number of events 221 • 4 years
|
18.5%
42/227 • Number of events 244 • 4 years
|
|
Investigations
Aspartate aminotransferase increased
|
14.5%
33/228 • Number of events 173 • 4 years
|
17.2%
39/227 • Number of events 189 • 4 years
|
|
Investigations
Blood bilirubin increased
|
5.7%
13/228 • Number of events 49 • 4 years
|
7.5%
17/227 • Number of events 65 • 4 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 11 • 4 years
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 11 • 4 years
|
|
Investigations
Cholesterol high
|
0.88%
2/228 • Number of events 9 • 4 years
|
0.00%
0/227 • 4 years
|
|
Investigations
Creatinine increased
|
7.9%
18/228 • Number of events 79 • 4 years
|
7.5%
17/227 • Number of events 42 • 4 years
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 10 • 4 years
|
|
Investigations
Investigations - Other, specify
|
3.1%
7/228 • Number of events 32 • 4 years
|
2.6%
6/227 • Number of events 48 • 4 years
|
|
Investigations
Lipase increased
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 20 • 4 years
|
|
Investigations
Lymphocyte count decreased
|
8.3%
19/228 • Number of events 92 • 4 years
|
14.5%
33/227 • Number of events 159 • 4 years
|
|
Investigations
Neutrophil count decreased
|
49.6%
113/228 • Number of events 440 • 4 years
|
55.1%
125/227 • Number of events 519 • 4 years
|
|
Investigations
Platelet count decreased
|
46.5%
106/228 • Number of events 918 • 4 years
|
43.2%
98/227 • Number of events 725 • 4 years
|
|
Investigations
Thyroid stimulating hormone increased
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Investigations
Weight gain
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Investigations
Weight loss
|
11.8%
27/228 • Number of events 146 • 4 years
|
14.1%
32/227 • Number of events 158 • 4 years
|
|
Investigations
White blood cell decreased
|
20.2%
46/228 • Number of events 231 • 4 years
|
25.6%
58/227 • Number of events 167 • 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
19.3%
44/228 • Number of events 184 • 4 years
|
21.1%
48/227 • Number of events 183 • 4 years
|
|
Metabolism and nutrition disorders
Blood bicarbonate decreased
|
0.44%
1/228 • Number of events 7 • 4 years
|
0.88%
2/227 • Number of events 5 • 4 years
|
|
Metabolism and nutrition disorders
Dehydration
|
6.6%
15/228 • Number of events 24 • 4 years
|
5.7%
13/227 • Number of events 63 • 4 years
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.00%
0/228 • 4 years
|
1.8%
4/227 • Number of events 24 • 4 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.3%
3/228 • Number of events 6 • 4 years
|
3.1%
7/227 • Number of events 10 • 4 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.3%
28/228 • Number of events 180 • 4 years
|
12.8%
29/227 • Number of events 222 • 4 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.88%
2/228 • Number of events 4 • 4 years
|
2.2%
5/227 • Number of events 5 • 4 years
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.88%
2/228 • Number of events 13 • 4 years
|
1.8%
4/227 • Number of events 6 • 4 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
1.3%
3/228 • Number of events 3 • 4 years
|
0.00%
0/227 • 4 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.8%
4/228 • Number of events 5 • 4 years
|
1.8%
4/227 • Number of events 8 • 4 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
4.4%
10/228 • Number of events 38 • 4 years
|
3.1%
7/227 • Number of events 18 • 4 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
1.3%
3/228 • Number of events 15 • 4 years
|
0.00%
0/227 • 4 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.44%
1/228 • Number of events 3 • 4 years
|
0.00%
0/227 • 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
13.2%
30/228 • Number of events 126 • 4 years
|
13.7%
31/227 • Number of events 146 • 4 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.6%
15/228 • Number of events 43 • 4 years
|
6.2%
14/227 • Number of events 38 • 4 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.88%
2/228 • Number of events 3 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.9%
34/228 • Number of events 65 • 4 years
|
14.1%
32/227 • Number of events 70 • 4 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.5%
17/228 • Number of events 67 • 4 years
|
6.6%
15/227 • Number of events 54 • 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.7%
29/228 • Number of events 153 • 4 years
|
13.7%
31/227 • Number of events 81 • 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.4%
10/228 • Number of events 21 • 4 years
|
2.6%
6/227 • Number of events 8 • 4 years
|
|
Metabolism and nutrition disorders
Metabolism, nutrition disord - Oth spec
|
2.6%
6/228 • Number of events 24 • 4 years
|
0.44%
1/227 • Number of events 3 • 4 years
|
|
Metabolism and nutrition disorders
Obesity
|
0.88%
2/228 • Number of events 11 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.3%
12/228 • Number of events 58 • 4 years
|
3.1%
7/227 • Number of events 30 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.2%
5/228 • Number of events 29 • 4 years
|
0.88%
2/227 • Number of events 28 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
24/228 • Number of events 86 • 4 years
|
8.4%
19/227 • Number of events 65 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.3%
3/228 • Number of events 5 • 4 years
|
3.1%
7/227 • Number of events 45 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.88%
2/228 • Number of events 15 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 3 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
4.8%
11/228 • Number of events 31 • 4 years
|
4.8%
11/227 • Number of events 36 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
4.8%
11/228 • Number of events 45 • 4 years
|
1.8%
4/227 • Number of events 13 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.2%
5/228 • Number of events 20 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
0.88%
2/228 • Number of events 4 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal, conn tissue - Oth spec
|
3.9%
9/228 • Number of events 50 • 4 years
|
2.6%
6/227 • Number of events 45 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
7/228 • Number of events 8 • 4 years
|
2.6%
6/227 • Number of events 9 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.8%
4/228 • Number of events 8 • 4 years
|
2.6%
6/227 • Number of events 10 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.44%
1/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.2%
21/228 • Number of events 103 • 4 years
|
7.9%
18/227 • Number of events 98 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, mal, uncpec - Oth spec
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
Nervous system disorders
Amnesia
|
0.44%
1/228 • Number of events 5 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Nervous system disorders
Anosmia
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Nervous system disorders
Dizziness
|
12.7%
29/228 • Number of events 53 • 4 years
|
8.4%
19/227 • Number of events 71 • 4 years
|
|
Nervous system disorders
Dysesthesia
|
3.1%
7/228 • Number of events 27 • 4 years
|
2.2%
5/227 • Number of events 18 • 4 years
|
|
Nervous system disorders
Dysgeusia
|
14.0%
32/228 • Number of events 199 • 4 years
|
18.1%
41/227 • Number of events 268 • 4 years
|
|
Nervous system disorders
Dysphasia
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 7 • 4 years
|
|
Nervous system disorders
Encephalopathy
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Nervous system disorders
Headache
|
11.4%
26/228 • Number of events 91 • 4 years
|
12.3%
28/227 • Number of events 112 • 4 years
|
|
Nervous system disorders
Hypersomnia
|
0.44%
1/228 • Number of events 10 • 4 years
|
0.88%
2/227 • Number of events 4 • 4 years
|
|
Nervous system disorders
Lethargy
|
0.88%
2/228 • Number of events 3 • 4 years
|
0.00%
0/227 • 4 years
|
|
Nervous system disorders
Memory impairment
|
0.88%
2/228 • Number of events 8 • 4 years
|
1.3%
3/227 • Number of events 7 • 4 years
|
|
Nervous system disorders
Nervous system disorders - Oth spec
|
2.6%
6/228 • Number of events 60 • 4 years
|
0.00%
0/227 • 4 years
|
|
Nervous system disorders
Neuralgia
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Nervous system disorders
Paresthesia
|
10.5%
24/228 • Number of events 139 • 4 years
|
14.5%
33/227 • Number of events 262 • 4 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.6%
6/228 • Number of events 20 • 4 years
|
2.2%
5/227 • Number of events 58 • 4 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
68.0%
155/228 • Number of events 1711 • 4 years
|
69.6%
158/227 • Number of events 1882 • 4 years
|
|
Nervous system disorders
Presyncope
|
0.44%
1/228 • Number of events 1 • 4 years
|
1.3%
3/227 • Number of events 3 • 4 years
|
|
Nervous system disorders
Somnolence
|
1.3%
3/228 • Number of events 3 • 4 years
|
0.00%
0/227 • 4 years
|
|
Nervous system disorders
Syncope
|
1.3%
3/228 • Number of events 4 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Nervous system disorders
Tremor
|
0.88%
2/228 • Number of events 3 • 4 years
|
1.3%
3/227 • Number of events 32 • 4 years
|
|
Psychiatric disorders
Anxiety
|
9.2%
21/228 • Number of events 79 • 4 years
|
7.5%
17/227 • Number of events 77 • 4 years
|
|
Psychiatric disorders
Confusion
|
1.3%
3/228 • Number of events 27 • 4 years
|
0.00%
0/227 • 4 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
Psychiatric disorders
Depression
|
6.1%
14/228 • Number of events 78 • 4 years
|
5.3%
12/227 • Number of events 65 • 4 years
|
|
Psychiatric disorders
Insomnia
|
13.6%
31/228 • Number of events 134 • 4 years
|
11.0%
25/227 • Number of events 187 • 4 years
|
|
Psychiatric disorders
Irritability
|
1.3%
3/228 • Number of events 7 • 4 years
|
0.00%
0/227 • 4 years
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.44%
1/228 • Number of events 2 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Psychiatric disorders
Restlessness
|
0.44%
1/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Psychiatric disorders
Suicidal ideation
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/228 • 4 years
|
1.3%
3/227 • Number of events 5 • 4 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.88%
2/228 • Number of events 7 • 4 years
|
2.2%
5/227 • Number of events 40 • 4 years
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
1.3%
3/228 • Number of events 4 • 4 years
|
1.8%
4/227 • Number of events 5 • 4 years
|
|
Renal and urinary disorders
Glucosuria
|
2.6%
6/228 • Number of events 32 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Renal and urinary disorders
Hematuria
|
3.9%
9/228 • Number of events 33 • 4 years
|
2.6%
6/227 • Number of events 18 • 4 years
|
|
Renal and urinary disorders
Proteinuria
|
10.5%
24/228 • Number of events 106 • 4 years
|
13.7%
31/227 • Number of events 116 • 4 years
|
|
Renal and urinary disorders
Renal and urinary disorders - Oth spec
|
2.6%
6/228 • Number of events 44 • 4 years
|
3.5%
8/227 • Number of events 55 • 4 years
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
Renal and urinary disorders
Urinary fistula
|
0.44%
1/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Renal and urinary disorders
Urinary frequency
|
1.3%
3/228 • Number of events 6 • 4 years
|
1.3%
3/227 • Number of events 4 • 4 years
|
|
Renal and urinary disorders
Urinary incontinence
|
1.8%
4/228 • Number of events 17 • 4 years
|
0.44%
1/227 • Number of events 5 • 4 years
|
|
Renal and urinary disorders
Urinary retention
|
0.44%
1/228 • Number of events 6 • 4 years
|
1.3%
3/227 • Number of events 10 • 4 years
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Renal and urinary disorders
Urinary urgency
|
0.44%
1/228 • Number of events 3 • 4 years
|
0.44%
1/227 • Number of events 3 • 4 years
|
|
Renal and urinary disorders
Urine discoloration
|
2.2%
5/228 • Number of events 23 • 4 years
|
0.44%
1/227 • Number of events 3 • 4 years
|
|
Reproductive system and breast disorders
Amenorrhea
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 34 • 4 years
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
1.8%
4/228 • Number of events 23 • 4 years
|
0.88%
2/227 • Number of events 10 • 4 years
|
|
Reproductive system and breast disorders
Irregular menstruation
|
0.44%
1/228 • Number of events 8 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.44%
1/228 • Number of events 3 • 4 years
|
1.8%
4/227 • Number of events 7 • 4 years
|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
0.44%
1/228 • Number of events 4 • 4 years
|
0.00%
0/227 • 4 years
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Reproductive system and breast disorders
Testicular disorder
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 21 • 4 years
|
|
Reproductive system and breast disorders
Testicular pain
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Reproductive system and breast disorders
Vaginal dryness
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 6 • 4 years
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
0.44%
1/228 • Number of events 3 • 4 years
|
0.00%
0/227 • 4 years
|
|
Reproductive system and breast disorders
Vaginal pain
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.2%
5/228 • Number of events 17 • 4 years
|
3.5%
8/227 • Number of events 22 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.1%
23/228 • Number of events 101 • 4 years
|
12.8%
29/227 • Number of events 109 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.1%
23/228 • Number of events 111 • 4 years
|
8.8%
20/227 • Number of events 91 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.8%
27/228 • Number of events 186 • 4 years
|
15.4%
35/227 • Number of events 180 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.2%
5/228 • Number of events 15 • 4 years
|
3.5%
8/227 • Number of events 62 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
4.4%
10/228 • Number of events 37 • 4 years
|
2.2%
5/227 • Number of events 5 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngopharyngeal dysesthesia
|
0.44%
1/228 • Number of events 7 • 4 years
|
0.00%
0/227 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.5%
8/228 • Number of events 36 • 4 years
|
4.4%
10/227 • Number of events 24 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal mucositis
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.44%
1/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 6 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
1.3%
3/228 • Number of events 3 • 4 years
|
1.8%
4/227 • Number of events 39 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.8%
4/228 • Number of events 6 • 4 years
|
2.2%
5/227 • Number of events 12 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Resp, thoracic, mediastinal - Oth spec
|
2.6%
6/228 • Number of events 40 • 4 years
|
2.2%
5/227 • Number of events 12 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.2%
5/228 • Number of events 75 • 4 years
|
2.2%
5/227 • Number of events 40 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.44%
1/228 • Number of events 6 • 4 years
|
0.00%
0/227 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.5%
8/228 • Number of events 11 • 4 years
|
2.6%
6/227 • Number of events 13 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
0.88%
2/228 • Number of events 21 • 4 years
|
0.00%
0/227 • 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.44%
1/228 • Number of events 2 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
8.3%
19/228 • Number of events 130 • 4 years
|
5.7%
13/227 • Number of events 152 • 4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.0%
16/228 • Number of events 80 • 4 years
|
5.7%
13/227 • Number of events 54 • 4 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 3 • 4 years
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 5 • 4 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
3.5%
8/228 • Number of events 32 • 4 years
|
1.8%
4/227 • Number of events 7 • 4 years
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.88%
2/228 • Number of events 17 • 4 years
|
1.3%
3/227 • Number of events 20 • 4 years
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
0.44%
1/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/228 • 4 years
|
1.3%
3/227 • Number of events 3 • 4 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrm
|
4.4%
10/228 • Number of events 106 • 4 years
|
4.8%
11/227 • Number of events 41 • 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.4%
10/228 • Number of events 30 • 4 years
|
4.0%
9/227 • Number of events 45 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
3.1%
7/228 • Number of events 55 • 4 years
|
1.3%
3/227 • Number of events 5 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.1%
7/228 • Number of events 25 • 4 years
|
5.7%
13/227 • Number of events 77 • 4 years
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcut tissue disord - Oth spec
|
2.2%
5/228 • Number of events 17 • 4 years
|
6.2%
14/227 • Number of events 31 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
8.8%
20/228 • Number of events 128 • 4 years
|
6.6%
15/227 • Number of events 182 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Vascular disorders
Arterial thromboembolism
|
0.44%
1/228 • Number of events 20 • 4 years
|
0.00%
0/227 • 4 years
|
|
Vascular disorders
Flushing
|
1.3%
3/228 • Number of events 3 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
Vascular disorders
Hematoma
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Vascular disorders
Hot flashes
|
2.6%
6/228 • Number of events 18 • 4 years
|
1.3%
3/227 • Number of events 3 • 4 years
|
|
Vascular disorders
Hypertension
|
58.8%
134/228 • Number of events 1432 • 4 years
|
59.9%
136/227 • Number of events 1659 • 4 years
|
|
Vascular disorders
Hypotension
|
3.1%
7/228 • Number of events 13 • 4 years
|
2.2%
5/227 • Number of events 9 • 4 years
|
|
Vascular disorders
Thromboembolic event
|
7.5%
17/228 • Number of events 115 • 4 years
|
5.7%
13/227 • Number of events 154 • 4 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
1.3%
3/228 • Number of events 21 • 4 years
|
0.44%
1/227 • Number of events 3 • 4 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.44%
1/228 • Number of events 1 • 4 years
|
1.3%
3/227 • Number of events 7 • 4 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.44%
1/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Endocrine disorders
Endocrine disorders - Other, specify
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Endocrine disorders
Hyperparathyroidism
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 3 • 4 years
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/228 • 4 years
|
1.3%
3/227 • Number of events 10 • 4 years
|
|
Eye disorders
Blurred vision
|
3.9%
9/228 • Number of events 26 • 4 years
|
0.88%
2/227 • Number of events 6 • 4 years
|
|
Eye disorders
Dry eye
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.88%
2/227 • Number of events 10 • 4 years
|
|
Eye disorders
Eye disorders - Other, specify
|
2.2%
5/228 • Number of events 36 • 4 years
|
1.3%
3/227 • Number of events 5 • 4 years
|
|
Eye disorders
Flashing lights
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 4 • 4 years
|
|
Eye disorders
Periorbital edema
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Eye disorders
Photophobia
|
0.44%
1/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Eye disorders
Vision decreased
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Eye disorders
Watering eyes
|
1.3%
3/228 • Number of events 16 • 4 years
|
1.3%
3/227 • Number of events 16 • 4 years
|
|
Gastrointestinal disorders
Abdominal distension
|
1.3%
3/228 • Number of events 3 • 4 years
|
3.1%
7/227 • Number of events 12 • 4 years
|
|
Gastrointestinal disorders
Abdominal pain
|
20.2%
46/228 • Number of events 139 • 4 years
|
20.7%
47/227 • Number of events 143 • 4 years
|
|
Gastrointestinal disorders
Anal fissure
|
0.88%
2/228 • Number of events 8 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Gastrointestinal disorders
Anal pain
|
1.8%
4/228 • Number of events 45 • 4 years
|
0.88%
2/227 • Number of events 29 • 4 years
|
|
Gastrointestinal disorders
Ascites
|
0.44%
1/228 • Number of events 13 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Belching
|
1.3%
3/228 • Number of events 14 • 4 years
|
1.3%
3/227 • Number of events 11 • 4 years
|
|
Gastrointestinal disorders
Bloating
|
0.88%
2/228 • Number of events 3 • 4 years
|
1.3%
3/227 • Number of events 9 • 4 years
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 9 • 4 years
|
|
Gastrointestinal disorders
Colitis
|
1.3%
3/228 • Number of events 3 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
Gastrointestinal disorders
Colonic fistula
|
0.44%
1/228 • Number of events 4 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Colonic perforation
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Constipation
|
34.2%
78/228 • Number of events 366 • 4 years
|
20.7%
47/227 • Number of events 225 • 4 years
|
|
Gastrointestinal disorders
Dental caries
|
1.3%
3/228 • Number of events 4 • 4 years
|
0.44%
1/227 • Number of events 3 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
52.6%
120/228 • Number of events 736 • 4 years
|
51.5%
117/227 • Number of events 673 • 4 years
|
|
Gastrointestinal disorders
Dry mouth
|
3.9%
9/228 • Number of events 30 • 4 years
|
4.0%
9/227 • Number of events 19 • 4 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
13/228 • Number of events 127 • 4 years
|
6.2%
14/227 • Number of events 58 • 4 years
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
6/228 • Number of events 27 • 4 years
|
3.1%
7/227 • Number of events 50 • 4 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Gastrointestinal disorders
Esophageal pain
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.88%
2/228 • Number of events 6 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Flatulence
|
3.1%
7/228 • Number of events 34 • 4 years
|
2.6%
6/227 • Number of events 17 • 4 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 11 • 4 years
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.6%
15/228 • Number of events 80 • 4 years
|
8.4%
19/227 • Number of events 99 • 4 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Oth spec
|
7.9%
18/228 • Number of events 93 • 4 years
|
6.6%
15/227 • Number of events 68 • 4 years
|
|
Gastrointestinal disorders
Gastroparesis
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Gastrointestinal disorders
Gingival pain
|
0.44%
1/228 • Number of events 27 • 4 years
|
0.44%
1/227 • Number of events 13 • 4 years
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
1.8%
4/228 • Number of events 4 • 4 years
|
1.8%
4/227 • Number of events 12 • 4 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.2%
5/228 • Number of events 11 • 4 years
|
2.6%
6/227 • Number of events 24 • 4 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
15.8%
36/228 • Number of events 167 • 4 years
|
20.3%
46/227 • Number of events 301 • 4 years
|
|
Gastrointestinal disorders
Nausea
|
61.0%
139/228 • Number of events 1043 • 4 years
|
60.8%
138/227 • Number of events 981 • 4 years
|
|
Gastrointestinal disorders
Oral dysesthesia
|
1.8%
4/228 • Number of events 14 • 4 years
|
1.8%
4/227 • Number of events 10 • 4 years
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.88%
2/228 • Number of events 5 • 4 years
|
0.44%
1/227 • Number of events 10 • 4 years
|
|
Gastrointestinal disorders
Oral pain
|
2.2%
5/228 • Number of events 13 • 4 years
|
1.8%
4/227 • Number of events 12 • 4 years
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 4 • 4 years
|
|
Gastrointestinal disorders
Proctitis
|
0.88%
2/228 • Number of events 2 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Rectal fissure
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 7 • 4 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
3.9%
9/228 • Number of events 16 • 4 years
|
1.8%
4/227 • Number of events 5 • 4 years
|
|
Gastrointestinal disorders
Rectal pain
|
3.9%
9/228 • Number of events 27 • 4 years
|
3.5%
8/227 • Number of events 16 • 4 years
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
0.44%
1/228 • Number of events 9 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 2 • 4 years
|
|
Gastrointestinal disorders
Stomach pain
|
2.2%
5/228 • Number of events 10 • 4 years
|
0.00%
0/227 • 4 years
|
|
Gastrointestinal disorders
Toothache
|
2.2%
5/228 • Number of events 28 • 4 years
|
1.8%
4/227 • Number of events 6 • 4 years
|
|
Gastrointestinal disorders
Vomiting
|
26.8%
61/228 • Number of events 142 • 4 years
|
28.6%
65/227 • Number of events 193 • 4 years
|
|
General disorders and administration site conditions
Chills
|
2.2%
5/228 • Number of events 8 • 4 years
|
4.8%
11/227 • Number of events 20 • 4 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.44%
1/228 • Number of events 5 • 4 years
|
0.88%
2/227 • Number of events 20 • 4 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.44%
1/227 • Number of events 8 • 4 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.88%
2/228 • Number of events 5 • 4 years
|
0.88%
2/227 • Number of events 8 • 4 years
|
|
Cardiac disorders
Chest pain - cardiac
|
1.3%
3/228 • Number of events 3 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/228 • 4 years
|
1.8%
4/227 • Number of events 6 • 4 years
|
|
Cardiac disorders
Sinus bradycardia
|
1.8%
4/228 • Number of events 12 • 4 years
|
2.2%
5/227 • Number of events 9 • 4 years
|
|
Cardiac disorders
Sinus tachycardia
|
5.3%
12/228 • Number of events 27 • 4 years
|
7.0%
16/227 • Number of events 41 • 4 years
|
|
Ear and labyrinth disorders
Ear pain
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.00%
0/227 • 4 years
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 17 • 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
37.7%
86/228 • Number of events 506 • 4 years
|
33.9%
77/227 • Number of events 492 • 4 years
|
|
Blood and lymphatic system disorders
Blood and lymph sys disorders - Oth Spec
|
3.5%
8/228 • Number of events 20 • 4 years
|
1.8%
4/227 • Number of events 28 • 4 years
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.44%
1/228 • Number of events 1 • 4 years
|
0.88%
2/227 • Number of events 3 • 4 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/228 • 4 years
|
0.88%
2/227 • Number of events 2 • 4 years
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/228 • 4 years
|
0.44%
1/227 • Number of events 1 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place